Study of Inspiratory Muscle Training Using PrO2 Device in Children Aged 6 to 17 with Moderate to Severe Asthma and Normal or Obese Body Weight

What this Trial Is About

Researchers are investigating the role of inspiratory muscle dysfunction and small airway dysfunction in children aged 6 to 17 years with moderate to severe asthma, comparing lean and obese groups. This study aims to understand how obesity contributes to asthma severity and breathing difficulties. It includes a randomized, sham-controlled trial to evaluate the effects of inspiratory muscle training on respiratory function. Participants will be assigned to one of three groups receiving inspiratory training at different intensities using a PrO2 device with biofeedback high dose 75% of maximum inspiratory pressure, low dose 40%, or sham training 15%. Training involves forceful inspirations through the device for 8 weeks, with a target of 150 inspirations three times weekly. The study includes cross-sectional assessments before the intervention and collects outcomes at the 8-week training endpoint. During the 10-week participation, children will undergo evaluations of respiratory mechanics and muscle function. Researchers will measure inspiratory muscle dysfunction and small airway dysfunction, as well as inspiratory muscle endurance. Data on asthma control, body mass index, and other factors will be collected. The study uses adherence monitoring through the devices app and includes safety and outcome assessments up to 10 weeks.

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)